Leica Microsystems

Leica Wireless Footswitch User Manual Ver 00

User Manual

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File Name: Leica Microsystems - Leica Wireless Footswitch User Manual Ver 00.pdf

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MEDICAL DIVISION

Leica Wireless Footswitch User Manual 10 746 233 - Version 00

Thank you for purchasing a Leica Wireless Footswitch. In developing our systems, we have placed great emphasis on simple, selfexplanatory operation. Nevertheless, we suggest studying this user manual in detail in order to utilize all the benefits of your new Leica Wireless Footswitch. For valuable information about Leica Microsystems products and services and the address of your nearest Leica representative, please visit our website, www.leica-microsystems.com Thank you for choosing our products. We hope that you will enjoy the quality and performance of your new Leica Wireless Footswitch. Leica Microsystems (Schweiz) AG Medical Division Max-Schmidheiny-Strasse 201 CH-9435 Heerbrugg Phone: +41 71 726 3333 Fax: +41 71 726 3334

Legal disclaimer All specifications are subject to change without notice. The information provided by this manual is directly related to the operation of the equipment.Medical decisions remain the responsibility of the clinician. Leica Microsystems has made every effort to provide a complete and clear user manual highlighting the key areas of product use. Should additional information regarding the use of the product be required, please contact your local Leica representative. You should never use a medical product of Leica Microsystems without the full understanding of the use and the performance of the product. Liability For our liability, please see our standard sales terms and conditions.Nothing in this disclaimer will limit any of our liabilities in any way that is not permitted under applicable law, or exclude any of our liabilities that may not be excluded under applicable law.

Leica Wireless footswitch / Ref. 10 746 233 / Version 00

Content 1

Introduction 1.1 About this user manual 1.2 Symbols in this user manual 1.3 Optional product characteristics 1.4 Product identification

2 2 2 2 2

Safety notes 2.1 Intended use 2.2 Information for the person responsible for the instrument 2.3 Instructions for the operator of the instrument 2.4 Dangers of use 2.5 Signs and labels

3 3

Function and Design 3.1 Function 3.2 Design

5 5 5

Operation 6 4.1 Marking the Leica Wireless Footswitch and receiver unit 6 4.2 Connecting the receiver unit of the Leica Wireless Footswitch 7 4.3 Replacing batteries 7 4.4 Emergency cable (optional) 7 4.5 Decomissioning 7

Manufacturer's declaration of electromagnetic compatibility (EMC) 5.1 Table 1 in accordance with IEC 60601-1-2 5.2 Table 2 in accordance with IEC 60601-1-2 5.3 Table 4 in accordance with IEC 60601-1-2 5.4 Table 6 in accordance with IEC 60601-1-2

8 8 9 10 11

Care and Maintenance 6.1 Cleaning and disinfection 6.2 Maintenance and repair 6.3 Battery storage

12 12 12 12

Disposal

Technical Data 8.1 Leica Wireless Footswitch 8.2 Electrical data 8.3 Wireless specifications 8.4 Ambient conditions 8.5 CE conformity 8.6 Limitations of use

13 13 13 13 13 13 13

3 3 4 4

Leica Wireless Footswitch / Ref. 10 746 233 / Version 00

Introduction

1.1

About this user manual

The Leica Wireless Footswitch is described in this User Manual. Leica Wireless Footswitch, 12 functions, Typ B Leica Wireless Footswitch, 14 functions, Typ B In addition to notes on the use of the instruments this user manual gives important safety information (see chapter "Safety notes").

XXRead this user manual carefully before operating the

product.

1.2

1.3

Optional product characteristics

Different product features and accessories are optionally available. The availability varies from country to country and is subject to local regulatory requirements. Please contact your local representative for availability.

1.4

Product identification

The model and serial numbers of your product are located on the identification label on the underside of the Leica Wireless Footswitch and the receiver unit. XXEnter this data in your user manual and always refer to it when you contact us or the service representative regarding any questions you may have. Type

Serial No.

...

Symbols in this user manual

The symbols used in this User Manual have the following meaning: Symbol

Warning word

Meaning

Warning

Indicates an imminently hazardous situation or improper use that could result in serious personal injuries or death.

Caution

Indicates a potentially hazardous situation or improper use which, if not avoided, may result in minor or moderate injury.

Note

Indicates a potentially hazardous situation or improper use which, if not avoided, may result in appreciable material, financial and environmental damage.. Information about use that helps the user to employ the product in a technically correct and efficient way.

Action required; this symbol indicates that you need to perform a specific action or series of actions.

Leica Wireless footswitch / Ref. 10 746 233 / Version 00

Safety notes

XXModifications and maintenance work on the Leica Wireless

The Leica Wireless Footswitch is state-of-the-art technology. Nevertheless, hazards can arise during operation. XXAlways follow the instructions in this user manual, and in particular the safety notes.

2.1

Intended use

• The Leica Wireless Footswitch is used exclusively for controlling movements of Leica surgical microscopes. The signals are transferred wirelessly. • The Leica Wireless Footswitch may be used only in closed rooms and must be placed on a solid floor. • The Leica Wireless Footswitch is subject to special precautionary measures for electromagnetic compatibility. It must be installed and commissioned in accordance with the guidelines and manufacturer's declaration and recommended safety distances (according to EMC tables based on IEC 60601‑1‑2). • Portable, mobile and fixed RF communication equipment can have a negative influence on the Leica Wireless Footswitch and its functionality.

2.2

Information for the person responsible for the instrument

XXEnsure that the Leica Wireless Footswitch is used only by

persons qualified to do so. XXEnsure that this user manual is always available at the place

where the Leica Wireless Footswitch is used. XXCarry out regular inspections to make certain that the authorized users are adhering to safety requirements. XXWhen instructing new users, do so thoroughly and explain the meanings of the warning signs and messages. XXAllocate responsibilities with respect to commissioning, operation and maintenance. Monitor compliance with this. XXOnly use the Leica Wireless Footswitch if it is free of defects. XXInform your Leica representative or Leica Microsystems (Schweiz) AG, Medical Division, 9435 Heerbrugg, Switzerland, immediately about any product defect that could potentially cause injury or harm. XXIf you use accessories from other manufacturers with the Leica Wireless Footswitch, make sure that these manufacturers confirm that the combination is safe to use. Follow the instructions in the user manual for those accessories.

Footswitch may be performed only by professionals expressly authorized by Leica Microsystems. XXOnly original Leica replacement parts may be used in servicing the product. XXAfter service work or technical modifications, the device must be readjusted in accordance with our technical specifications. XXIf the instrument is modified or serviced by unauthorized persons, is improperly maintained (as long as maintenance was not carried out by us), or is handled improperly, Leica Microsystems will not accept any liability. XXThe effect of the Leica Wireless Footswitch on other instruments has been tested as specified in IEC 60601-1-2. The system passed the emission and immunity test. Comply with the usual precautionary and safety measures relating to electromagnetic and other forms of radiation. XXThe electric installation in the building must conform to the national standard, e.g. current-operated ground leakage protection (fault-current protection) is suggested. XXLike any other instrument in the operating theater, this system may fail. Leica Microsystems (Schweiz) AG therefore recommends that a backup system be kept available during the operation.

2.3

Instructions for the operator of the instrument

XXFollow the instructions described here. XXFollow the instructions given by your employer regarding the

organization of work and safety at work.

Leica Wireless Footswitch / Ref. 10 746 233 / Version 00

Safety notes

2.4

Dangers of use

2.5

NOTE

Signs and labels

Label on the Wireless Footswitch

Possible damage to the Leica Wireless Footswitch! XXUse only batteries recommended by Leica Microsystems (3 × LR14 (Type C) = 4.5 V). XXWhen inserting the batteries, ensure that the polarity is correct.

Label on the receiver unit

Leica Wireless footswitch / Ref. 10 746 233 / Version 00

Function and Design

3.1

Function

Using the Leica Wireless Footswitch, specific functions and settings (such as focus and zoom) for the surgical microscope can be controlled wirelessly by foot. A signal is transmitted from the transmitter unit in the Leica Wireless Footswitch to the receiver unit on the control unit. The standard configuration of the pedals and switches can be assigned individually for each user in the configuration menu. For more information, refer to the User Manual of the respective microscope.

3.2

Design

3.2.1

Leica Wireless Footswitch

1 Indicator 2 Joystick for controlling movements on the microscope 3 LED connect 4 LED battery 5 Handle 6 Push buttons (14 functions ) 7 Pedals 8 Footrest 9 Battery compartment 10 Plug for emergency cable (power supply) 11 Push buttons (12 functions )

The Leica Wireless Footswitch is equipped with a position sensor. The buttons on the Leica Wireless Footswitch no longer respond on an incline of more than 35°. To release the automatic safety function, press a control element twice on the Leica wireless footswitch.

The LEDs (3 and 4) indicate the respective operating state of the Leica Wireless Footswitch. LED

Operating state

CONNECT (3)

• Is illuminated in green: wireless connection produced, footswitch ready to operate • Is flashing in green: No wireless connection • Off: Wireless Footswitch is in energy-saving mode

Battery (4)

• • • •

Is illuminated in green: Batteries ok Is illuminated in orange: Batteries weak Is flashing in orange: Batteries very weak Is flashing quickly in orange: Batteries are empty, no wireless connection • Off: Wireless Footswitch is in energy-saving mode

Leica Wireless Footswitch / Ref. 10 746 233 / Version 00

Operation

3.2.2

Receiver unit

Operation

4.1

Marking the Leica Wireless Footswitch and receiver unit

The Leica Wireless Footswitch and its receiver unit are marked before use to uniquely define pairs of equipment and prevent a mix-up.

XXAffix the provided sticker (1) to the receiver unit (2) or the

stand. XXSet the number on the indicator (3). This number is located on

the sticker (1).

12 LED power 13 LED connect 14 LED battery 15 Connector for control unit The LEDs (12 and 13) on the receiver unit indicate the respective operating state of the Leica Wireless Footswitch. LED

Operating state

POWER (11)

• Is illuminated in green: Leica receiver is ready to operate. • Off: Receiver unit switched off

CONNECT (12) • Illuminated in blue: Radio contact to the transmitter unit produced in the Leica Wireless Footswitch. • Is illuminated in red: Wireless contact produced, range exceeded. • Off: No radio contact to the transmitter unit in the Leica Wireless Footswitch for more than 3.5 seconds Battery (13)

• • • •

Remove the batteries if the Leica Wireless Footswitch will not be used for a long period of time. Wireless coupling of the receiver unit and transmitter unit with the wireless footswitch can only be carried out by the responsible Leica service organization.

Battery status for Leica Wireless Footswitch: Is illuminated in green: Batteries ok Is flashing in orange: Batteries very weak Off: Leica Wireless Footswitch switched off

Leica Wireless footswitch / Ref. 10 746 233 / Version 00

Operation

4.2

Connecting the receiver unit of the Leica Wireless Footswitch

XXInsert the plug of the receiver unit into the "Control" or "FOOT/

HAND 1/2" socket of the Leica surgical microsocpe.

XXInsert the new batteries. XXThe ejector ribbon must be postioned inside the battery

compartment below the batteries. XXClose the battery-compartment cover (2) again.

Ensure that the polarity is correct

XXSwitch on the surgical microscope.

The LED for indicating the operating state illuminates in green.

The IP X8 protection class is only ensured if the ejector ribbon is correctly positioned within the battery compartment.

XXCheck the user presets on the control unit of your Leica Surgical

Microscope. Test all functions of the Leica Wireless Footswitch. (Control unit of the Leica Surgical Microscope.)

4.3

Replacing batteries

NOTE Possible damage to the Leica Wireless Footswitch! XXUse only batteries recommended by Leica Microsystems (3 × LR14 (Type C) = 4.5 V). XXWhen inserting the batteries, ensure that the polarity is correct.

4.4

Emergency cable (optional)

If the batteries fail, the optional emergency cable can be used to ensure that the power supply is working.

4.5

Decomissioning

When the microscope is switched off, the receiver unit is disabled. The wireless connection is only established if the joystick, push buttons or pedals on the Leica Wireless Footswitch are actuated.

If the LEDs on the Leica Wireless Footswitch and receiver unit illuminates in orange, the batteries of the Leica Wireless Footswitch must be replaced at the next available opportunity. Always keep at least 3 replacement batteries on hand. XXRelease 2 locks (1) on the rear side of the Leica Wireless

Footswitch. XXOpen the battery-compartment cover (2). XXRemove the empty batteries (3) and dispose of them in

accordance with the respective applicable national laws.

XXPosition the ejector ribbon below the batteries.

Leica Wireless Footswitch / Ref. 10 746 233 / Version 00

Manufacturer's declaration of electromagnetic compatibility (EMC)

Manufacturer's declaration of electromagnetic compatibility (EMC) This "Guidance and manufacturer's declaration" document is based on IEC 60601-1-2.

5.1

Table 1 in accordance with IEC 60601-1-2

Guidance and manufacturer's declaration - electromagnetic emissions The Leica Wireless Footswitch is intended for use in the electromagnetic environment specified below. The customer or the user of the Leica Wireless Footswitch should ensure that it is used in such an environment. Emissions test

Compliance

Electromagnetic environment - guidance

RF emissions in accordance with CISPR 11

Group 1

The Leica Wireless Footswitch uses RF energy only for its internal function. Therefore, its RF emissions are very low and it is not likely to cause any interference in nearby electronic equipment.

RF emissions in accordance with CISPR 11

Class A

Harmonic emissions in accordance with IEC 61000-3-2

Class A

The Leica Wireless Footswitch is intended for use in establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Emissions of voltage fluctuations / flicker in accordance with IEC 61000-3-3

Complies

Leica Wireless footswitch / Ref. 10 746 233 / Version 00

Manufacturer's declaration of electromagnetic compatibility (EMC)

5.2

Table 2 in accordance with IEC 60601-1-2

Guidance and manufacturer's declaration - electromagnetic immunity The Leica Wireless Footswitch is intended for use in the electromagnetic environment specified below. The customer or the user of the Leica Wireless Footswitch should ensure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment – guidance

Electrostatic discharge (ESD) in accordance with IEC 61000-4-2

±4 kV contact discharge

±8 kV air discharge

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

Electrical fast transient/ burst immunity according to IEC 61000-4-4

Not applicable

Surges according to IEC 61000-4-5

Not applicable

Voltage dips, short interruptions and power supply voltage fluctuations IEC 61000-4-11

Not applicable

Magnetic fields for the Not applicable supply frequency (50/60 Hz) according to IEC 61000-4-8

Not applicable

Mains power quality should be that of a typical commercial or hospital environment.

The magnetic fields on the power frequency should correspond to that of a typical business or hospital environment.

Leica Wireless Footswitch / Ref. 10 746 233 / Version 00

Manufacturer's declaration of electromagnetic compatibility (EMC)

5.3

Table 4 in accordance with IEC 60601-1-2

IEC 60601 test level

Compliance

Electromagnetic environment – guidance

Conducted RF – interference in accordance with IEC 61000-4-6

3 Veff 150 kHz to 80 MHz

3 Veff

Portable and mobile RF communications should be used no closer to any part of the Leica Wireless Footswitch, including its cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Conducted RF – interference in accordance with IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

3 V/m Recommended separation distance: d = 2.4 √P for 150 kHz to 80 MHz d = 2.4 √P for 80 MHz to 2.5 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol:

Note 1:

At 80 MHz, the higher frequency range applies

Note 2:

These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Leica Wireless Footswitch is used exceeds the compliance levels listed above, the Leica Wireless Footswitch should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Leica Wireless Footswitch. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Leica Wireless footswitch / Ref. 10 746 233 / Version 00

Manufacturer's declaration of electromagnetic compatibility (EMC)

5.4

Table 6 in accordance with IEC 60601-1-2

Recommended separation distances between portable and mobile RF telecommunications equipment and the Leica Wireless Footswitch The Leica Wireless Footswitch is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Leica Wireless Footswitch can help prevent electromagnetic interference by maintaining a minimum distance between portable RF communications equipment (transmitters) and the Leica Wireless Footswitch – depending on the output power of the communication equipment, as specified below. Separation distance according to frequency of transmitter in m Rated maximum output power of transmitter W

150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz

d = 2.4 √P in m

0,01

0,24

0,1

0,8

2,40

8,0

100

24,0

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note:

These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Using accessories or cables other than those specified here or as approved by the manufacturer of the Leica Wireless Footswitch can lead to elevated electromagnetic emissions or reduced interference resistance. The Leica Wireless Footswitch may not be used in direct proximity of other instruments. If it is necessary to operate them in the vicinity of other instruments, the microscopes should be monitored to ensure that they function properly in this arrangement

Leica Wireless Footswitch / Ref. 10 746 233 / Version 00

Care and Maintenance

6.1

Cleaning and disinfection

The respective applicable national laws must be observed for disposal of the products, with the involvement of corresponding disposal companies. The unit packaging is to be recycled.

XXBefor cleaning, switch off your Leica cireless Footswitch.

Disposal

The Leica Wireless Footswitch must be cleaned after each clinical use to prevent instrument malfunctions due to dirt and bacteria. When using detergents and disinfectants, you must comply with the general regulations for personal protection. The corresponding manufacturer regulations for detergents and disinfectants must also be observed. The Leica Wireless Footswitch is not to be subjected to sterilization. Only exclusively protected, manual cleaning methods are permitted. XXUse soft, lint-free cloths. Never use pure alcohol or solvents as disinfectants because these substances attack surfaces. The footswitch must be cleaned using a cloth with disinfectant and lukewarm water. Only Isopropanol 70 %, neoform MED rapid and Bacillol AF may be used as detergents.

6.2

Maintenance and repair

The Leica Wireless Footswitch is basically maintenance-free. To ensure that it always operates safely and reliably, we recommend that you observe the notes in your microscope's user manual. In case of defects, contact the responsible service organization.

6.3

Battery storage

XXStore the batteries in a cool, dark and dry

room.

Leica Wireless footswitch / Ref. 10 746 233 / Version 00

Technical Data

8.4

8.1

Leica Wireless Footswitch

Use

System General classification Protection class Exterior dimensions Weight

Leica Wireless Footswitch, 12 functions Leica Wireless Footswitch, 14 functions Protection class I IP X8 approx. 420 × 242 × 120 (L × W × H in mm) max. 4 kg

Ambient conditions

Transport and storage (without batteries) Transport and storage (with batteries)

+10 °C to +40 °C (+50 °F to +104 °F) 30 % to 90 % relative humidity, noncondensing –20 °C to +70 °C (–4 °F to +158 °F) 10 % to 90 % relative humidity, noncondensing –18 °C to +55 °C (0 °F to +131 °F) 10 % to 90 % relative humidity, noncondensing

8.2

Electrical data

8.5

8.2.1

Footswitch

• Medical Devices Directive 93/42/EEC including amendments. • Classification: Class I, in compliance with Annex IX, Rule 1, and Rule 12 of the Medical Devices Directive. • Medical electrical equipment, Part 1: Generally defined for the security in IEC 60601-1;EN 60601-1; UL 60601-1; CAN/CSA-C22.2 NO. 601.1-M90. • Electromagnetic compatibility IEC 60601-1-2; EN 60601-1-2. • The Medical Division, within Leica Microsystems (Schweiz) AG, holds the management system certificates for the international standards ISO 9001, ISO 13485 and ISO 14001 relating to quality management, quality assurance and environmental management.

Power supply Switch-on current (Ia)

8.2.2

Receiver unit

Power supply communication Protection class RS232 data rate

8.3

3x LR14(Type C) = 4.5V, batteries ~ 30 mA

5 V, <100 mA RS232 IP40 4.8 kbaud (UART)

Wireless specifications

Limitations of use

Leica Wireless Footswitches may be operated at Leica Microsystems surgical microscopes only.

Performance capacity

Range RF data rate

8.6

CE conformity

10 m < 250 kbps

Wireless technology

Frequency range Channel spacing Modulation

2400–2483.5 MHz 500 kHz 2-FSK; MSK

Compliance

Europe USA

EN 300440 - EN 301489 FCC, Part 15C, single modular - FCC identifier: XK5-SW100AMBINT (footswitch) XK5-SW100AMBEXT (receiver) Canada RSS-210 Issue 7, - IC identifier: 5158A-SW100AMBINT (footswitch) 5158A-SW100AMBEXT (receiver)

Leica Wireless Footswitch / Ref. 10 746 233 / Version 00

www.leica-microsystems.com

The fruitful collaboration ”with the user, for the user“ has always been the foundation of Leica Microsystems‘ innovative strength. On this basis, we have developed our five corporate values: Pioneering, High-end Quality, Team Spirit, Dedication to Science, and Continuous Improvement.

Leica Microsystems – an international company with a strong network of worldwide customer services: Active worldwide USA ∙ Buffalo Grove/Illinois Canada ∙ Concord/Ontario

Tel. +1 800 248 0123 +1 800 248 0123

Fax +1 847 405 0164 +1 847 405 0164

MeDICaL DIvISIOn What does a surgeon expect from an outstanding surgical microscope? Sharp, clear images, and a modular system aligned with the surgeon and OR staff needs.

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Innovations for your practice From the first surgical microscope with widefield optics in the 1980s to the first microscopes with Horizontal Optics and with LeD illumination, Leica Microsystems has been at the forefront of innovation in the development of surgical microscopes. HD video, fluorescence and retinal viewing systems also demonstrate the continued innovative nature of the Leica team. We strive to provide the surgeon with leading edge technology to enhance performance, surgeon comfort, and patient outcomes.

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10 746 233en/00 • Copyright © by Leica Microsystems (Schweiz) AG, Medical Division, CH-9435 Heerbrugg, 2015 • Printed – II.2015 – • Subject to change. • LEICA and the Leica Logo are registered trademarks of Leica Microsystems IR GmbH.

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